The Commission has taken note of the article published in PLoS Medicine. It does not accept that British American Tobacco or the European Policy Centre unduly influenced either the Commission's Impact Assessment system or Better Regulation strategy. While stakeholder views were duly taken into account in the initial steps taken, these views were received from a large variety of interest groups and were critically assessed.

The Commission Impact Assessment system explicitly aims to involve all interested parties from the earliest stages of this process. It has been widely welcomed as making a major contribution to increased transparency and openness of the process of policy development. The Impact Assessment Guidelines stress the need for the Commission services to ensure that all relevant stakeholders are able to contribute to consultations, and these consultations have to be as transparent and accountable as possible. Engagement and transparency is at the heart of the impact assessment Guidelines, the Minimum Standards for Consultation and the Commission's overall approach to Smart Regulation.

The Commission Impact Assessment system is specifically designed to take an integrated approach that gives appropriately balanced attention to economic, environmental and social impacts. The Commission is, nevertheless, aware of the need to make continuous efforts to improve the quality of its analysis. The President of the Commission emphasised the importance of strengthening the assessment of social impacts (in his speech to Parliament on 15 September 2009). To this end, the Commission (the Directorate-General for Employment, Social Affairs and Inclusion, and the Directorate-General for Health and Consumer Policy) has developed improved and extensive supplementary guidance on the assessment of a broad range of social impacts, including public health impacts.

In his political guidelines for this Commission, published in September 2009, the President of the Commission underlined the importance of ‘empowering citizens to be involved in decisions affecting their lives, including by ensuring transparency on how they are taken’.To achieve transparency about lobbying, the Commission has established the Register of Interest Representatives(1). With close to 3 000 organisations now registered, the public can see that the Commission does not operate in isolation from the civil society's concerns and interests, but interacts with them in an open and inclusive fashion, creating a level playing field for all categories of interests.